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Sr Consultant

Date Posted: Oct 23, 2026

Job Detail

  • location_on
    Location Noida, Uttar Pradesh, India
  • desktop_windows
    Job Type: Full Time/Permanent
  • schedule
    Shift:
  • analytics
    Career Level:
  • group
    Positions:
  • calendar_view_day
    Experience:
  • male
    Gender: No Preference
  • school
    Degree:
  • calendar_month
    Apply Before: Dec 07, 2026

Job Description

Job Summary

Job Title: CSV Infrastructure Qualification (GxP)

Job Description: The position is responsible for end‑to‑end CSV Infrastructure Qualification for GxP‑regulated environments, ensuring compliance with FDA, GAMP5, EU Annex 11, and client Quality Systems.
The role provides quality leadership across Design & Engineering, Implementation, and BAU operations for on‑prem, virtual, cloud infrastructure, including large‑scale Server Appliance deployments across global sites.

Key Responsibility

  • CSV Infrastructure Qualification
  • GxP compliance across infrastructure lifecycle
  • Audit readiness and regulatory alignment
  • Quality oversight for multi‑year, large‑scale Server Appliance implementations

Roles & Responsibilities:

  • Define qualification strategy
  • Lead and govern execution of Infrastructure IQ, OQ activities.
  • Ensure vendor documentation and supplier qualification evidence meet GxP expectations.
  • Oversee change, deviation, and CAPA management during implementation.
  • Act as Quality SPOC for project audits and client reviews.
  • Ensure right‑first‑time qualification and inspection‑ready documentation
  • Govern ongoing compliance of qualified infrastructure in BAU.
  • Perform and oversee: Periodic reviews, Change impact assessments and requalification decisions, Incident, deviation, and CAPA oversight
  • Ensure infrastructure changes, patches, and upgrades follow controlled CSV processes.
  • Maintain continuous audit readiness for BAU environments.

 

Technical & Regulatory Expertise

  • GAMP 5, FDA 21 CFR Part 11, EU Annex 11
  • Infrastructure Qualification (on‑prem, virtual, cloud)
  • Data Integrity (ALCOA+)
  • Risk‑based validation and lifecycle management

Qualification: Minimum - B.Pharm/M.Pharm, B.E/ B. Tech, (MBA / MCA / MTech is an added advantage)

Experience:

  • Minimum 10 years of experience in Computer System Validation
  • Hands‑on experience in Infrastructure Qualification is mandatory, including multi‑site or large‑scale deployments

Capabilities and Certifications:

  • Professional Services background including exposure to GAMP / CSV, ITIL, Cloud certifications (AWS / Azure – GxP exposure)
  • Must Demonstrate Good Communication and Presentation Skills

Key Responsibilities

Key Responsibility

  • CSV Infrastructure Qualification
  • GxP compliance across infrastructure lifecycle
  • Audit readiness and regulatory alignment
  • Quality oversight for multi‑year, large‑scale Server Appliance implementations

Skill Requirements

Technical & Regulatory Expertise

  • GAMP 5, FDA 21 CFR Part 11, EU Annex 11
  • Infrastructure Qualification (on‑prem, virtual, cloud)
  • Data Integrity (ALCOA+)
  • Risk‑based validation and lifecycle management

Qualification: Minimum - B.Pharm/M.Pharm, B.E/ B. Tech, (MBA / MCA / MTech is an added advantage)

Experience:

  • Minimum 10 years of experience in Computer System Validation
  • Hands‑on experience in Infrastructure Qualification is mandatory, including multi‑site or large‑scale deployments

Other Requirements

Capabilities and Certifications:

  • Professional Services background including exposure to GAMP / CSV, ITIL, Cloud certifications (AWS / Azure – GxP exposure)
  • Must Demonstrate Good Communication and Presentation Skills

 

Source: HCLTech careers — Read the original posting and apply

This role is listed by the employer on its own careers site. Kaam Ki Khoj does not process applications for it.

Company Overview

HCLTech
HCLTech · Noida, Uttar Pradesh, India
4,246 open roles

HCLTech is an employer in the IT/Computers - Software, Software Services sector with operations in India. This is a directory listing maintained by Kaam Ki Khoj so that candidates can find the organisation; it is not an official company page and Kaam... Read More

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